medwireNews: Phase IIa trial results suggest that treatment with the anti-CD40 monoclonal antibody CFZ533 improves disease activity and is well tolerated in patients with clinically active primary Sjögren’s syndrome.
After 12 weeks of treatment, the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) score was reduced by an average of 6.35 points for the 21 patients randomly allocated to receive intravenous CFZ533 10 mg/kg and by 1.27 points for the 11 participants given placebo. This equated to a significant between-group difference of 5.64 favoring the active therapy, which exceeded the proof-of-concept criterion of a difference of at least 5 points.
Both groups subsequently received the monoclonal antibody for a further 12 weeks, during which time the ESSDAI decrease was sustained in the CFZ533 arm and the original placebo group also started to show some improvement, the presenting author reported at the 2017 ACR/ARHP Annual Meeting in San Diego, California, USA.
He added that CFZ533 was well tolerated, with no unexpected safety results, no evidence of an increased infection risk, and no incidence of thromboembolic events.
Benjamin Fisher (University of Birmingham, UK) told delegates that CD40 has a critical role in germinal center reactions and other immune-mediated functions that are implicated in the pathogenesis of the disease. And he added that the study provides proof-of-concept that CD40 inhibition has potential in this patient population and supports the continued development of the CFZ533 clinical program.
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